The Blue Cross and Blue Shield Association announced this week it was calling on Congress to create an independent institute tasked with studying medical procedures, techniques, drugs and devices and determining which work best.
The Chicago-based umbrella organization for 39 for-profit and not-for-profit Blues plans also said it is willing to put its members' money where its mouth is by vowing to help fund operations of the institute, but not the whole tab. The association also called for other plans as well as Medicare, Medicaid and other government-funded payers to kick in financially.
A similar call for an independent research organization was made last month by America's Health Insurance Plans, a Washington-based trade group for the health insurance industry that counts among its members a majority of the Blues-affiliated health plans. Both groups seek to create an independent, public-private organization that would perform research in some areas already being addressed by a relatively new program under the federally funded Agency for Healthcare Research and Quality.
The Blues association said the proposed new institute was "an important component of a multipronged strategy (Blues) will be announcing in the coming months to improve healthcare value and quality for consumers," according to a news release issued Monday. The Blues did not respond to several calls for more details about its proposal by deadline.
According to the Blues proposal, the institute would support research into the efficacy of new vs. existing medical procedures, drugs, devices and biologics. It would be governed by a board of directors whose members would be drawn from both the public and private sectors.
A stable funding mechanism would be required, according to the Blues, which proposes assessing all private and public payers.
In a written statement, Blues President and Chief Executive Officer Scott Serota said obtaining credible information on the most effective treatments "holds the most promise for improving the value and quality of our system. Today, patients often are paying for suboptimal care. This institute is an important step to assuring that we are providing the best incentives to deliver the best care."
According to the text of his speech Monday at the National Press Club in Washington, Serota estimated the institute will cost $500 million in its first year, "a substantial amount," but "only a fraction of the nation's more than $2 trillion in annual health expenditures." Serota said the Blues plans are prepared to pay "our fair share," but did not specify an amount. Elliott Fisher is a professor of medicine and community and family medicine at Dartmouth Medical School and a member of its Center for the Evaluative Clinical Sciences as well as a member of the Institute of Medicine of the National Academies of Science. Fisher served as co-chairman of an IOM subcommittee on performance measures of its Committee on Redesigning Health Insurance Performance Measures, Payment and Performance Improvement Programs. In 2005, the committee issued a 384-page report, Performance Measurement: Accelerating Improvement, that called for a national quality coordination board, which would perform tasks in the Blues proposal, according to Fisher.
"Do we need a substantial investment in comparative research? The answer is clearly yes," Fisher said. The National Institutes of Health, the nation's oldest and foremost public research organization with a budget of nearly $27.9 billion, needs help in this area, according to Fisher. "The NIH primarily focuses on the development of new biomedical knowledge," he said. "It occasionally funds the studies of current treatments or the best treatment alternatives."
But, according to Fisher, "Most people think it takes too long to evaluate new treatments against the best current alternatives.
I will be encouraging Congress to broaden the scope (of the Blues proposal) to include quality measurements as well as comparative effectiveness research," Fisher said. "There are lots of different entities developing measures. All of those measurement efforts are based on a consensus process which limits the capacity of those developing the measures to be as bold as we need to be in defining what is high-quality care and in measuring the quality of the system.
"There are a number of gaps," he said. "The current measurement sets focus on individual providers, when one of our current problems is performance across providers of care." Currently, healthcare stakeholders push only for measures around which a consensus can be achieved, thus "there is risk that we'll only get the lowest-common denominator instead of ones that will move the performance of the whole system."
The question of who should pay for this new research and measurement development is a separate issue, Fisher said.The Food and Drug Administration is under mounting criticism for accepting pharmaceutical industry funding under the 1992 Prescription Drug User Fee Act for its drug review and approval processes. Pharma paid $305 million in fees during the current fiscal year, according to the consumer-advocacy group Public Citizen.
Fisher said curbing undue payer influence is an issue to be dealt with when the institute is structured.
"Most importantly, it should be an independent entity," Fisher said. "I think the degree of public trust will hinge on the independence of the entity. If it's established by Congress, has an independent board of governors and it is protected from commercial pressures, I wouldnt be concerned about the insurance industry sharing in its cost."
Like Fisher, Peter Lurie, deputy director of Public Citizens Health Research Group, thinks the research aims of the proposed institute are fine, but he is not as sanguine as Fisher about payer financing.
"This is a function that the government ought to be filling," Lurie said. "The concern would be, as long as part of the funding is private, the private funders might be pulling the strings as to what products get studied and how."
Lurie said the current FDA approval standard for a new drug does not require it be more effective than existing drugs. And even as proposed, if the institute does comparative analysis, it will be analyzed after the drug or procedure is on the market and considerable money has been wasted, or in the worst-case scenario, after damage has been done to patients.
"We'd like to see things sorted out when things come onto the market, rather than when they become a public health problem," Lurie said.
Finally, Lurie said Public Citizen opposes a portion of the Blues proposal that would give "safe harbor" from noneconomic and punitive damages in medical malpractice lawsuits to "physicians who rely on practice guidelines established through the institute's research."
"That's just a sop to physicians and the insurance companies," Lurie said.
Jean Slutsky, AHRQ's director of the Center for Outcomes and Evidence, a program created under the Medicare Modernization Act of 2003, says the center has received $15 million a year since its first appropriation in mid-2004, and has been up and running for about 18 months.
Not surprisingly, Slutsky said there is a "growing consensus" that the subject of the center's work, effective research, is "critically important." The center approaches a research topic by performing a meta-analysis of the existing literature and prepares a report.
"In those reports, we also identify gaps in the research that could inform future studies," Slutsky said. Then it boils down the analysis in readily usable forms for clinicians, patients and policymakers and posts them along with the full report to its Web site. The center has several research projects already completed, including comparisons of treatments for gastroesophageal reflux diseases and pain medications for patients with osteoarthritis.
"Obviously, the amount of work you can do is predicated on the amount of funding that you have," Slutsky said. "This particular program has been authorized and had money appropriated. One of the hallmarks of our program is transparency and the rigor in which we do our work."
Mohit Ghose, spokesman for the insurance industry trade group AHIP, said his organization came up with a similar call for an independent organization to study efficacy of treatments and procedures in a broader proposal on quality and safety it released about a month ago.
"The key difference is we did not put a price tag on ours," Ghose said. "We won't know what the price tag is until we know how it is made up."
And there is no knock from the plans on AHRQ, or even an expanded government effort in what AHRQ is doing, he said. "We have always supported additional funding for AHRQ."
The problem is, there is a "tremendous disconnect" between what the government spends on research and what is spent on dissemination of the results of that research.
"The issue here is to create an absolutely independent entity that can provide objective data in the long run," he said. Healthcare, he added, needs to be able to rely "on the most clinically effective and the best data that is out there in driving coverage and in driving value and is driving purchasing."
Ghose said he was unaware of any legislation pending that would create the research institute.What do you think? Write us with your comments at [email protected]. Please include your name, title and hometown.